Combination Photodynamic Devices

ABSTRACT

Combination photodynamic devices for repair and stabilization of a fractured or a weakened bone are disclosed herein. In an embodiment, a combination photodynamic device includes a load bearing member and one or more conformable members connected to the load bearing member, the conformable member expandable from a deflated state to an inflated state. The load bearing member is designed to reside inside a cavity of fractured or weakened bone and act as internal bone fixation and stabilization device. The conformable member is designed to anchor the load bearing member inside a bone cavity, transform the load bearing member from a flexible state to a rigid state, contribute to fixating and stabilizing a fractured or a weakened bone, and provide longitudinal and rotational stability to a fractured or a weakened bone during the healing process or combinations thereof.

RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. ProvisionalPatent Application No. 61/509,314, filed on Jul. 19, 2011, U.S.Provisional Patent Application No. 61/509,391, filed on Jul. 19, 2011,and U.S. Provisional Patent Application No. 61/509,459, filed on Jul.19, 2011, the entirety of these applications are hereby incorporatedherein by reference.

FIELD

The embodiments disclosed herein relate to bone implants, and moreparticularly to combination photodynamic devices for bone repair andstabilization.

BACKGROUND

Bones form the skeleton of the body and allow the body to be supportedagainst gravity and to move and function in the world. Bone fracturescan occur, for example, from an outside force or from a controlledsurgical cut (an osteotomy). A fracture's alignment is described as towhether the fracture fragments are displaced or in their normal anatomicposition. In some instances, surgery may be required to re-align andstabilize the fractured bone. It is often difficult to properly positionand stabilize fractured or weakened bones. It would be desirable to havean improved device for repairing and stabilizing a fractured or weakenedbone.

SUMMARY

Combination photodynamic devices for repair and stabilization of afractured or a weakened bone are disclosed herein. In one aspect, thereis a provided a combination photodynamic device that includes at leastone load bearing member designed to reside in a cavity of a fractured orweakened bone, and at least one conformable member connected to the atleast one load bearing member. The at least one load bearing member actsas an internal bone fixation and stabilization device. The at least oneconformable member is configured to be expandable from a deflated stateto an inflated state to anchor the at least one load bearing memberinside the cavity.

In one embodiment, the at least one conformable member is expandablefrom a deflated state to an inflated state using an expansion fluid. Inan embodiment, the at least one conformable member is a balloon. In anembodiment, the at least one conformable member is designed to transformthe at least one load bearing member from a flexible state for deliveryto or removal from the cavity of the bone to a rigid state forimplantation within the cavity of the bone. In an embodiment, the atleast one conformable member is detachably or removably attached to theat least one load bearing member.

In an embodiment, the at least one load bearing member has a threadedend so that the at least one load bearing member can be screwed into thebone. In an embodiment, the at least one load bearing member is anelongated rod or an intramedullary nail. In an embodiment, the at leastone load bearing member is made of a flexible material. In anembodiment, the at least one load bearing member includes a plurality ofnested tubes telescopically slidable relative to one another. In anembodiment, the at least one load bearing member has a compressible bodythat can be transformed from a flexible state to a rigid state by acompressive force. In an embodiment, the at least one load bearingmember is transformable between a flexible state and a rigid state byradially expanding the at least one load bearing member using theconformable member placed inside the load bearing member. In anembodiment, the at least one load bearing member is as at leastpartially enclosed by the at least one conformable member. In anembodiment, the at least one load bearing member is adjacent to the atleast one conformable member. In an embodiment, the at least one loadbearing member is a flexible patterned tube or a flexible helicalspring, and the at least one conformable member is configured to beinserted in the at least one load bearing member and expanded totransform the at least one load bearing member to a rigid state.

In an embodiment, the device includes one or more holes in the at leastone load bearing member and/or at least one conformable member forreceiving one or more fasteners to secure the device to the bone. In anembodiment, the device includes a cam structure attached to the at leastone load bearing member and configured to act upon the at least oneconformable member to increase pressure between the at least one loadbearing member containing the cam structure, the at least oneconformable member, and/or the weakened or fractured bone to stabilizethe load bearing member in the cavity of the bone. In an embodiment, theat least one load bearing member includes one or more segments.

In one aspect, a combination photodynamic device kit includes: at leastone expansion fluid; a delivery catheter having an elongated shaft witha proximal end, a distal end, and a longitudinal axis therebetween; aconformable member releasably engaged to the distal end of the deliverycatheter and wherein the delivery catheter has an inner void for passingthe at least one expansion fluid into the conformable member; and a loadbearing member, wherein the load bearing member can be engaged with theconformable member. In an embodiment, the kit also includes a pluralityof conformable members of different sizes or shapes.

In one aspect, a method for bone repair and stabilization includes:inserting a load bearing member into a cavity of a fractured or weakenedbone; inserting one or more conformable members into the cavity;engaging the one or more conformable members with the load bearingmember; and expanding the conformable member with an expansion fluid,thereby anchoring the load bearing member inside the cavity andproviding longitudinal and rotational stability to the load bearingmember during the healing process. In an embodiment, the load bearingmember is flexible when inserted into the cavity, and becomes rigid uponexpanding the conformable member with an expansion fluid.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1A shows a schematic illustration of an embodiment of a combinationphotodynamic implant including a load bearing member and a conformablemember.

FIG. 1B shows a schematic illustration of an embodiment of a combinationphotodynamic implant including multiple load bearing members.

FIG. 1C shows a schematic illustration of an embodiment of a combinationphotodynamic implant having a threaded end.

FIG. 2 shows a schematic illustration of an embodiment of a bone implantsystem. The system includes a light source, a light pipe, an attachmentsystem, a light-conducting fiber, a light-sensitive liquid, a deliverycatheter and a conformable member.

FIG. 3A and FIG. 3B show close-up cross-sectional views of the regioncircled in FIG. 2. FIG. 3A shows a cross-sectional view of a distal endof the delivery catheter and the conformable member prior to the devicebeing infused with light-sensitive liquid. FIG. 3B shows across-sectional view of the distal end of the delivery catheter and theconformable member after the device has been infused withlight-sensitive liquid and light energy from the light-conducting fiberis introduced into the delivery catheter and an inner lumen of theconformable member to cure the light-sensitive liquid.

FIG. 4A and FIG. 4B illustrate an embodiment of a combinationphotodynamic implant having a single-piece load bearing member.

FIG. 5A illustrates an embodiment of a combination photodynamic implantin which a load bearing member is made of a series of telescoping tubes.

FIG. 5B illustrates an embodiment of a combination photodynamic implantin which a load bearing member is a compressible body.

FIG. 5C and FIG. 5D illustrate an embodiment of a combinationphotodynamic implant in which a conformable member engages a loadbearing member and provides interference in compression or tension tofeatures of the load bearing member.

FIGS. 6A-6D illustrate an embodiment of a combination photodynamicimplant in which a load bearing member is transformable from a flexiblestate to a rigid state by a conformable member or a portion thereof.

FIG. 7A and FIG. 7B illustrate an embodiment of a combinationphotodynamic implant in which a load bearing member is enclosed within aconformable member.

FIG. 8A and FIG. 8B illustrate an embodiment of a combinationphotodynamic implant including one or more conformable members.

FIG. 8C-8F illustrate embodiments of a combination photodynamic implantincluding an internal cam structure.

FIG. 8G and FIG. 8H illustrate an embodiment of a combinationphotodynamic implant including one or more conformable members.

FIG. 9A and FIG. 9B illustrate an embodiment of a combinationphotodynamic implant having a modular load bearing member.

FIGS. 10A-10F show an embodiment of method steps for using the systemsand device.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

Medical devices and methods for repairing and stabilizing a weakened orfractured bone are disclosed herein. As shown in FIG. 1A, a combinationphotodynamic device 100 of the present disclosure includes a loadbearing member 115 and one or more conformable members 170 associatedwith the load bearing member 115. The term “associated with” as usedherein means, either fixedly or removably, connected to, affixed to,incorporated into, linked with, attached to, wrapped around, insertedinto, mounted over, received in, or any other physical connection. In anembodiment, the combination photodynamic device 100 can include multipleload bearing members 115a, 115b, as shown in FIG. 1B. The load bearingmember 115 is designed to reside inside of a cavity 101 of a bone 105and act as an internal bone fixation and stabilization device during thehealing of a bone fracture 104. The terms “cavity within a bone” and“bone cavity” as used herein is intended to include both naturalcavities within a bone, such as the intramedullary cavity,physician-created cavities, and also cavities created due to bonediseases. The conformable member 170 is designed to anchor the loadbearing member 115 inside the bone cavity 101 and to providelongitudinal and rotational stability to the load bearing member 115during the healing of the bone fracture 104. Additionally oralternatively, the conformable member 170 is designed to transform theload bearing member 115 from a flexible state for delivery to a bonecavity to a rigid state once inside the bone cavity inside the bonecavity 101. It should be noted that in some combination photodynamicimplants of the present disclosure, the conformable member can alsofunction to fixate and stabilize a fractured or weakened bone or toprovide longitudinal and rotational stability to a fractured or weakenedbone, either in combination with or independently of the load bearingmember 115.

A combination photodynamic device may be used to treat a fractured orweakened bone. The combination photodynamic devices of the presentdisclosure are suitable to treat a fractured or weakened tibia, fibula,humerus, ulna, femur, radius, metatarsals, metacarpals, phalanx,phalanges, ribs, spine, vertebrae, clavicle, pelvis, wrist, mandible,and other bones and still be within the scope and spirit of thedisclosed embodiments. In an embodiment, a combination photodynamicdevices of the present disclosure is used to stabilize, reinforce orsupport a weakened bone. In an embodiment, a combination photodynamicdevices of the present disclosure is used to stabilize a fractured bonein conjunction with anatomic reduction (i.e., proper reorientation offractured elements to their original position, both relative to oneanother and relative to other adjacent anatomical features).

As used herein, the terms “fracture” or “fractured bone” refer to apartial or complete break in the continuity of a bone. The fracture canoccur, for example, from an outside force or from a controlled surgicalcut (osteotomy). A combination photodynamic implant can be used to treatany type of bone fracture, including, but not limited to, a displacedfracture, a non-displaced fracture, an open fracture, a closed fracture,a hairline fracture, a compound fracture, a simple fracture, amulti-fragment fracture, a comminuted fracture, an avulsion fracture, abuckle fracture, a compacted fracture, a stress fracture, a compressionfracture, multiple fractures in a bone, spiral fracture, butterflyfracture, other fractures as described by AO Foundation coding, andother types of fractures.

As used herein, the term “weakened bone” refers to a bone with apropensity toward a fracture due to a decreased strength or stabilitydue to a disease or trauma. Some bone diseases that weaken the bonesinclude, but are not limited to, osteoporosis, achondroplasia, bonecancer, fibrodysplasia ossificans progressiva, fibrous dysplasia, leggcalve perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis,osteopenia, osteoporosis, Paget's disease, and scoliosis. Weakened bonesare more susceptible to fracture, and treatment to prevent bonefractures may be desirable.

In an embodiment, the combination photodynamic implant may be used tostabilizing fractured or weakened load bearing bones including, but notlimited to, the femur and tibia bones of the leg. The use of thecombination implant, in an embodiment, allows for strength of the loadbearing member to be imparted through the use of metal or structuralplastics like those listed above and other suitable materials. In anembodiment, use of the combination implant allows for minimally invasiveplacement since the load bearing member can be a small diameter butfilling the internal cavity can be accomplished with the conformablemember(s). In an embodiment, the combination implant can provide therequired stability with potentially significant load carrying capacityincrease due to the use of particular metal load bearing andphotodynamic conformable members.

In an embodiment, the load bearing member 115 is sufficiently designedfor implantation into a bone cavity via a minimally invasive method. Theload bearing member 115 may be flexible or rigid. In an embodiment, theload bearing member 115 is in a flexible state for delivery to a bonecavity and is transformed to a rigid state once inside the bone cavity.In an embodiment, the load bearing member 115 is transformable from aflexible state to a rigid state by the conformable member 170. The loadbearing member 115 can comprise a single piece or multiple pieces.

The load bearing member 115 can be made from a variety of biocompatiblematerials including, but not limited to, metal, composite, plastic oramorphous materials, which include, but are not limited to, steel,stainless steel, cobalt chromium plated steel, titanium, nickel titaniumalloy (nitinol), superelastic alloy, and polymethylmethacrylate (PMMA),poly-ether ether ketone (PEEK), composite materials of polymers andminerals, composite materials of polymers and glass or polymeric fibers,composite materials of metal, polymer, and minerals and any otherengineering materials.

Referring to FIG. 1B, when implanted within a bone cavity, in additionto being held in place with the one or more conformable members 170, thephotodynamic implant 100 may further be held in place by any suitablefasteners 102, including, but not limited to, screws, pins, wires,nails, and bolts. In an embodiment, the load bearing member 115 mayinclude one or more holes 104 for receiving fasteners 102 that can beinserted through the bone to secure the combination photodynamic implant100 in place. In an embodiment, the holes 104 are located at theproximal and distal ends of the load bearing member 115. In anembodiment, the load bearing member 115 are made of a material intowhich fasteners 102 can be inserted without providing pre-drilled holesin the load bearing member 115, such as polyether ether ketone (PEEK).In such an embodiment, fasteners 102 can be inserted into the loadbearing member 115 at a user selected location anywhere along a lengthof the load bearing member 115, at any angle and to any desired depth. Acombination implant of a load bearing member 115 made of a material,such as PEEK, combined with a conformable member 170, allowsuser-selected insertion of fasteners 102 at any location along theimplant, at any angle or desired depth, transiting any combination ofbone, conformable member 170, and/or load bearing member 115 as desiredby the user. Additionally or alternatively, in an embodiment, fasteners102 can also be inserted into the conformable member 170 at a userselected location, at any angle and to any desired depth. Because thefasteners can be inserted at user-selected locations, the user is ableto determine the optimal placement for fasteners based on each patient'sspecific situation rather than on the predrilled holes. In addition,flexible fastener placements simplifies the procedure by enabling theuser to have a cross-locking screw without targeting to “find”pre-drilled holes.

In an embodiment, as shown in FIG. 1C, one end of the load bearingmember 115 is adapted for insertion into a cortical bone. In anembodiment, the load bearing member includes a threaded end 103 suchthat the load bearing member 115 can be securely screwed into corticalbone. In an embodiment, the threaded end 103 of the load bearing memberis tapered to facilitate insertion of the threaded end 103 into corticalbone.

In an embodiment, the conformable member 170 is a balloon expandablefrom a deflated state to an inflated state by the addition of at leastone expansion fluid. Modification of expansion fluid infusion allows auser to adjust the size and shape of the conformable member 170 in itsinflated state, as is described above. Because the shape and size of theconformable members 170 are easily configurable by the user, theconformable member 170 can be adjusted to achieve a conformal fit withthe cavity into which the combination photodynamic implant 100 isimplanted, thereby ensuring that the implanted combination photodynamicimplant 100 is longitudinally and rotationally secured inside the bonecavity. In an embodiment, the conformable member 170 can be adjusted toconform to the internal diameter of the bone cavity into which thecombination photodynamic implant 100 is implanted as well as thecurvature of the bone cavity. In an embodiment, the conformable member170 is adjusted to transform the load bearing member 115 from a flexiblestate to a rigid state. In an embodiment, the conformable member 170 isadjusted to facilitate fixation, stabilization, or both of the fracturedor weakened bone into which it is inserted.

In an embodiment, the expansion fluid is a curable liquid, that is aliquid that can progress from a flowable form for delivery to theconformable member 170, such as, for example, through a catheter, to anon-flowable (e.g., cured) form for final use in vivo. A cure may referto any chemical, physical, and/or mechanical transformation. In anembodiment, the expansion fluid is a light-sensitive liquid 165, whichcan be cured inside the conformable member 170 by exposing it to lightenergy, as is described in more detail below. The term “curable” mayrefer to uncured liquid, having the potential to be cured in vivo (as bycatalysis or the application of a suitable energy source), as well as toa liquid in the process of curing (e.g., a composition formed at thetime of delivery by the concurrent mixing of a plurality of compositioncomponents). Curing the curable expansion fluid inside the conformablemember 170 affixes the conformable member 170 in an expanded shape toform a photodynamic implant. It should be understood that a photodynamicimplant will have the size and shape substantially similar to aconformable member from which the photodynamic implant is formed.Although a combination photodynamic implant with the conformable member170 containing a cured curable liquid can be removed from the bonecavity, to simplify the removal of a combination photodynamic implant,the conformable member 170 can be expanded with a fluid that remainsflowable inside the conformable member 170 so that the conformablemember 170 can be easily deflated and removed, if necessary, therebyfacilitating the removal of the load bearing member. Suitable examplesof non-curable fluids include, but are not limited to, air, water orbuffer solution or any other fluid that is non-curable. It should benoted that in an embodiment, the conformable member 170 can be formed bya cured light sensitive liquid, without a balloon.

In an embodiment, the expansion fluid may be provided as a unit dose. Asused herein, the term “unit dose” is intended to mean an effectiveamount of light sensitive liquid adequate for a single session. By wayof a non-limiting example, a unit dose of a light sensitive liquid ofthe present disclosure for expanding the conformable member 170 may bedefined as enough expansion fluid to expand the conformable member 170to a desired shape and size. The desired shape and size of theconformable member 170 may vary somewhat from patient to patient. Thus,a user using a unit dose may have excess expansion fluid left over. Itis desirable to provide sufficient amount of expansion fluid toaccommodate even the above-average patient. In an embodiment, a unitdose of a expansion fluid of the present disclosure is contained withina container. In an embodiment, a unit dose of a expansion fluid of thepresent disclosure is contained in an ampoule. In an embodiment, theconformable member 170 is sufficiently shaped and sized to fit within aspace or a gap in a fractured bone. In an embodiment, the expansionfluid can be delivered under low pressure via a standard syringeattached to the port.

The conformable member 170 may be provided with a shape demanded by, forexample, the anatomy of the implantation site, characteristics of theload bearing member 115 or both. Suitable shapes include, but notlimited to, round, flat, cylindrical, dog bone, barbell, tapered, oval,conical, spherical, square, rectangular, toroidal and combinationsthereof. The conformable member 170 can be manufactured from anon-compliant (non-stretch/non-expansion) conformable materialincluding, but not limited to urethane, polyethylene terephthalate(PET), nylon elastomer and other similar polymers. In an embodiment, theconformable member 170 is manufactured from a polyethylene terephthalate(PET). In an embodiment, the conformable member 170 is manufactured froma radiolucent material, which permit x-rays to pass through theconformable member 170. In an embodiment, the conformable member 170 ismanufactured from a radiolucent polyethylene terephthalate (PET). In anembodiment, the conformable member 170 is manufactured from aconformable compliant material that is limited in dimensional change byembedded fibers. In an embodiment, at least a portion of the externalsurface of the conformable member 170 is substantially even and smooth.

In an embodiment, at least a portion of the external surface of theconformable member 170 includes at least one textured element such as abump, a ridge, a rib, an indentation or any other shape. In anembodiment, at least a portion of the external surface of theconformable member 170 protrudes out to form a textured element. In anembodiment, at least a portion of the external surface of theconformable member 170 invaginates to form a textured element. In anembodiment, the textured element increases the friction and improves thegrip and stability of the conformable member 170 after the conformablemember 170 is inserted into the fracture location. In an embodiment, thetextured element results in increased interdigitation of bone-deviceinterface as compared to an conformable member without texturedelements. In an embodiment, the textured element can be convex in shape.In an embodiment, the textured element can be concave in shape. In anembodiment, the textured element can be circumferential around the widthof the conformable member 170, either completely or partially.

In general, bone graft or bone graft substitute can be used inconjunction with an conformable member 170 of the present disclosure. Inan embodiment, the bone graft is an allogeneic bone graft. In anembodiment, the bone graft is an autologous bone graft. In anembodiment, the bone graft substitute is a hydroxyapatite bonesubstitute. In an embodiment, a bone graft or bone graft substitute isused to fill in any gaps that may exist, for example, between theexternal surface of the conformable member 170 and the surfaces of thebone fragments. In an embodiment, a bone graft or bone graft substituteis used to fill any gaps that may exist, for example, between thetextured element of the conformable member 170 and the surfaces of thebone fragments.

In general, the conformable member 170 can include an external surfacethat may be coated with materials including, but not limited to, drugs(for example, antibiotics), proteins (for example, growth factors) orother natural or synthetic additives (for example, radiopaque orultrasonically active materials). For example, after a minimallyinvasive surgical procedure an infection may develop in a patient,requiring the patient to undergo antibiotic treatment. An antibioticdrug may be added to the external surface of the conformable member 170to prevent or combat a possible infection. Proteins, such as, forexample, bone morphogenic protein or other growth factors have beenshown to induce the formation of cartilage and bone. A growth factor maybe added to the external surface of the conformable member 170 to helpinduce the formation of new bone. Due to the lack of thermal egress ofthe light-sensitive liquid 165 in the conformable member 170, theeffectiveness and stability of the coating is maintained.

In general, the conformable member 170 typically does not have anyvalves. One benefit of having no valves is that the conformable member170 may be expanded or reduced in size as many times as necessary toassist in the fracture reduction and placement. Another benefit of theconformable member 170 having no valves is the efficacy and safety ofthe system 100. Since there is no communication passage oflight-sensitive liquid 165 to the body there cannot be any leakage ofliquid 165 because all the liquid 165 is contained within theconformable member 170. In an embodiment, a permanent seal is createdbetween the conformable member 170 and the delivery catheter 150 that isboth hardened and affixed prior to the delivery catheter 150 beingremoved.

In an embodiment, abrasively treating the external surface of theconformable member 170, for example, by chemical etching or airpropelled abrasive media, improves the connection and adhesion betweenthe external surface of the conformable member 170 and a bone surface.The surfacing significantly increases the amount of surface area thatcomes in contact with the bone which can result in a stronger grip.

FIG. 2 in conjunction with FIG. 3A and FIG. 3B show schematicillustrations of an embodiment of a system 200 that can be used toimplant the conformable member 170 and infuse the expansion fluid intothe conformable member 170. In the embodiment where the expansion fluidis a light-sensitive liquid 165, the system 200 can also be used to curethe light-sensitive liquid 165 inside the conformable member 170. System200 includes a light source 110, a light pipe 120, an attachment system130 and a light-conducting fiber 140. The attachment system 130communicates light energy from the light source 110 to thelight-conducting fiber 140. In an embodiment, the light source 110 emitsfrequency that corresponds to a band in the vicinity of 390 nm to 770nm, the visible spectrum. In an embodiment, the light source 110 emitsfrequency that corresponds to a band in the vicinity of 410 nm to 500nm. In an embodiment, the light source 110 emits frequency thatcorresponds to a band in the vicinity of 430 nm to 450 nm. The system200 further includes a flexible delivery catheter 150 having a proximalend that includes at least two ports and a distal end terminating in anconformable member 170. In an embodiment, the conformable member 170 issufficiently shaped to fit within a space or a gap in a fractured bone.In an embodiment, the conformable member 170 is manufactured from anon-compliant (non-stretch/non-expansion) conformable material. In anembodiment, the conformable member 170 is manufactured from aconformable compliant material that is limited in dimensional change byembedded fibers. One or more radiopaque markers, bands or beads may beplaced at various locations along the conformable member 170 and/or theflexible delivery catheter 150 so that components of the system 200 maybe viewed using fluoroscopy.

In the embodiment shown in FIG. 2, the proximal end includes two ports.One of the ports can accept, for example, the light-conducting fiber140. The other port can accept, for example, a syringe 160 housing alight-sensitive liquid 165. In an embodiment, the syringe 160 maintainsa low pressure during the infusion and aspiration of the light-sensitiveliquid 165. In an embodiment, the syringe 160 maintains a low pressureof about 10 atmospheres or less during the infusion and aspiration ofthe light-sensitive liquid 165. In an embodiment, the light-sensitiveliquid 165 is a photodynamic (light-curable) monomer. In an embodiment,the photodynamic (light-curable) monomer is exposed to an appropriatefrequency of light and intensity to cure the monomer inside theconformable member 170 and form a rigid structure. In an embodiment, thephotodynamic (light-curable) monomer 165 is exposed to electromagneticspectrum that is visible (frequency that corresponds to a band in thevicinity of 390 nm to 770 nm). In an embodiment, the photodynamic(light-curable) monomer 165 is radiolucent, which permit x-rays to passthrough the photodynamic (light-curable) monomer 165.

As illustrated in FIG. 3A and FIG. 3B, the flexible delivery catheter150 includes an inner void 152 for passage of the light-sensitive liquid165, and an inner lumen 154 for passage of the light-conducting fiber140. In the embodiment illustrated, the inner lumen 154 and the innervoid 152 are concentric to one another. The light-sensitive liquid 165has a low viscosity or low resistance to flow, to facilitate thedelivery of the light-sensitive liquid 165 through the inner void 152.In an embodiment, the light-sensitive liquid 165 has a viscosity ofabout 1000 cP or less. In an embodiment, the light-sensitive liquid 165has a viscosity ranging from about 650 cP to about 450 cP. Theconformable member 170 may be inflated, trial fit and adjusted as manytimes as a user wants with the light-sensitive liquid 165, up until thelight source 110 is activated, when the polymerization process isinitiated. Because the light-sensitive liquid 165 has a liquidconsistency and is viscous, the light-sensitive liquid 165 may bedelivered using low pressure delivery and high pressure delivery is notrequired, but may be used.

In an embodiment, a contrast material may be added to thelight-sensitive liquid 165 without significantly increasing theviscosity. Contrast materials include, but are not limited to, bariumsulfate, tantalum, or any other suitable contrast materials. Thelight-sensitive liquid 165 can be introduced into the proximal end ofthe flexible delivery catheter 150 and passes within the inner void 152of the flexible delivery catheter 150 up into an inner cavity 172 of theconformable member 170 to change a thickness of the conformable member170 without changing a width or depth of the conformable member 170. Inan embodiment, the light-sensitive liquid 165 is delivered under lowpressure via the syringe 160 attached to the port. The light-sensitiveliquid 165 can be aspirated and reinfused as necessary, allowing forthickness adjustments to the conformable member 170 prior to activatingthe light source 110 and converting the liquid monomer 165 into a hardpolymer.

As illustrated in FIG. 2 in conjunction with FIG. 3B, thelight-conducting fiber 140 can be introduced into the proximal end ofthe flexible delivery catheter 150 and passes within the inner lumen 154of the flexible delivery catheter 150 up into the conformable member170. The light-conducting fiber 140 is used in accordance to communicateenergy in the form of light from the light source to the remotelocation. The light-sensitive liquid 165 remains a liquid monomer untilactivated by the light-conducting fiber 140 (cures on demand). Radiantenergy from the light source 110 is absorbed and converted to chemicalenergy to polymerize the monomer. The light-sensitive liquid 165, onceexposed to the correct frequency light and intensity, is converted intoa hard polymer, resulting in a rigid structure or photodynamic implant.In an embodiment, the monomer 165 cures in about five seconds to aboutfive minutes. This cure affixes the conformable member 170 in anexpanded shape to form a photodynamic implant.

Light-conducting fibers use a construction of concentric layers foroptical and mechanical advantages. The light-conducting fiber can bemade from any material including, but not limited to, glass, silicon,silica glass, quartz, sapphire, plastic, combinations of materials, orany other material, and may have any diameter. In an embodiment, thelight-conducting fiber is made from a polymethyl methacrylate core witha transparent polymer cladding. The light-conducting fiber can have adiameter between approximately 0.75 mm and approximately 2.0 mm. In someembodiments, the light-conducting fiber can have a diameter of about0.75 mm, about 1 mm, about 1.5 mm, about 2 mm, less than about 0.75 mmor greater than about 2 mm. In an embodiment, the light-conducting fibermay be made from a polymethyl methacrylate core with a transparentpolymer cladding. It should be appreciated that the above-describedcharacteristics and properties of the light-conducting fibers areexemplary and not all embodiments of the present disclosure are intendedto be limited in these respects. Light energy from a visible emittinglight source can be transmitted by the light-conducting fiber. In anembodiment, visible light having a wavelength spectrum of between about380 nm to about 780 nm, between about 400 nm to about 600 nm, betweenabout 420 nm to about 500 nm, between about 430 nm to about 440 nm, isused to cure the light-sensitive liquid.

The most basic function of a fiber is to guide light, i.e., to keeplight concentrated over longer propagation distances—despite the naturaltendency of light beams to diverge, and possibly even under conditionsof strong bending. In the simple case of a step-index fiber, thisguidance is achieved by creating a region with increased refractiveindex around the fiber axis, called the fiber core, which is surroundedby the cladding. The cladding may be protected with a polymer coating.Light is kept in the “core” of the light-conducting fiber by totalinternal reflection. Cladding keeps light traveling down the length ofthe fiber to a destination. In some instances, it is desirable toconduct electromagnetic waves along a single guide and extract lightalong a given length of the guide's distal end rather than only at theguide's terminating face.

In some embodiments of the present disclosure, at least a portion of alength of an light-conducting fiber is modified, e.g., by removing thecladding, in order to alter the profile of light exuded from thelight-conducting fiber. The term “profile of light” refers to, withoutlimitation, direction, propagation, amount, intensity, angle ofincidence, uniformity, distribution of light and combinations thereof.In an embodiment, the light-conducting fiber emits light radially in auniform manner, such as, for example, with uniform intensity, along alength of the light-conducting fiber in addition to or instead ofemitting light from its terminal end/tip. To that end, all or part ofthe cladding along the length of the light-conducting fiber may beremoved. It should be noted that the term “removing cladding” includestaking away the cladding entirely to expose the light-conducting fiberas well as reducing the thickness of the cladding. In addition, the term“removing cladding” includes forming an opening, such as a cut, a notch,or a hole, through the cladding. In an embodiment, removing all or partof the cladding may alter the propagation of light along thelight-conducting fiber. In another embodiment, removing all or part ofthe cladding may alter the direction and angle of incidence of lightexuded from the light-conducting fiber.

In an embodiment, the cladding is removed by making a plurality of cutsin the cladding to expose the core of the light-conducting fiber. In anembodiment, the cladding is removed in a spiral fashion. In anembodiment, the cladding is removed in such a way that a similar amountof light is exuded along the length of the modified section of thelight-conducting fiber. In another embodiment, the cladding is removedin such a way that the amount of light exuded along the length of themodified section of the light-conducting fiber changes from the distalend to the proximal end of the modified section. In another embodiment,the cladding is removed in such a way that the amount of light exudedalong the modified section of the light-conducting fiber decreases fromthe distal end of the modified section of the light-conducting fibertoward the proximal end thereof. In an embodiment, to alter the profileof the light exuded from the modified section, the cuts in the claddingare located along the length of the fiber in a spiral. In an embodiment,the pitch or spacing between the cuts is varied along the length of themodified section of the light-conducting fiber. In an embodiment, thespacing between the cuts increases from the proximal end of the modifiedsection of the light-conducting fiber 165 to the distal end thereof suchthat the amount of light exuded from the modified section of thelight-conducting fiber progressively increases toward the distal end ofthe modified section of the light-conducting fiber.

Once the light-sensitive liquid 165 is cured within the conformablemember 170 to form a photodynamic implant, the light conducting fiber165 is withdrawn from the system 200 and the conformable member 170 isseparated from the delivery catheter 150. In an embodiment, a separationarea is located at the junction between the distal end of theconformable member 170 and the delivery catheter 150 to facilitate therelease of the photodynamic implant 510 from the delivery catheter 150.The separation area ensures that there are no leaks of reinforcingmaterial from the elongated shaft of the delivery catheter and/or theconformable member 170. The separation area seals the photodynamicimplant and removes the elongated shaft of the delivery catheter bymaking a break at a known or predetermined site (e.g., a separationarea). The separation area may be various lengths and up to about aninch long. The separation area may also a stress concentrator, such as anotch, groove, channel or similar structure that concentrates stress inthe separation area. The stress concentrator is designed to ensure thatthe conformable member 170 is separated from the delivery catheter 150at the separation area. When torque (twisting) is applied to thedelivery catheter 150, the conformable member 170 separates from theshaft of the delivery catheter 150. The twisting creates a sufficientshear to break the residual reinforcing material and create a cleanseparation of the conformable member 170/shaft interface. It should ofcourse be understood that the conformable member 170 may be separatedfrom the delivery catheter 150 by any other means known and used in theart.

FIGS. 4-9 show various non-limiting embodiments of combinationphotodynamic implants of the present disclosure. It should be noted thatthe load bearing member and the conformable member in each embodimentdescribed below are not limited to features specifically described inconnection with the particular embodiment, but may also can includefeatures of the load bearing members and conformable members describedabove and features of the load bearing members and conformable membersdescribed in connection with other embodiments.

Referring to FIG. 4A and FIG. 4B, in an embodiment, a combinationphotodynamic implant 400 includes a load bearing member 115 and one ormore conformable members 170 associated with the bearing member 115. Inan embodiment, the load bearing member 115 is a rigid elongated roddesigned for implantation into a bone cavity. In an embodiment, the loadbearing member 115 is a rigid intramedullary nail, made of a metallicmaterial such as stainless steel or titanium. In an embodiment, the loadbearing member 115 is made of a flexible or semi-rigid material, such asPEEK, fiber reinforced composite polymers, or another engineeringthermoplastic. The one or more conformable members 170 may be disposedat the ends of the load bearing member 115, as shown in FIG. 4A, or adistance away from the ends of the load bearing member 115, as shown inFIG. 4B. Although the combination photodynamic implant 400 in FIG. 4Aand FIG. 4B is illustrated as having two conformable members 170, thecombination photodynamic implant 400 can include any number ofconformable members 170. The conformable member 170 can be positionedand engage the load bearing member 115 to provide longitudinal placementstability of the load bearing member 115, rotational placement stabilityof the load bearing member 115, or both. In an embodiment, thesestabilizing actions impart both positional stability of the combinationphotodynamic implant 400, as well as provide stability to the intendeduse of the bone and implant combination.

FIG. 5A and FIG. 5B illustrate embodiments of a combination photodynamicimplant 500 in which a load bearing member 115 may be transformablebetween a flexible state and a rigid state. The load bearing member 115can be transformed between a flexible state for delivery to or removalfrom a bone cavity to a rigid state for implantation within the bonecavity. In an embodiment, the load bearing member 115 comprises aplurality of nested tubes 502, 504, 506 telescopically slidable onewithin another, as shown in FIG. 5A. In an embodiment, the telescopictubes 502, 504, 506 may include a locking mechanism (not shown) suchthat the telescopic tubes 502, 504, 506 are slidable relative to oneanother when unlocked and fixed in position relative to one another whenlocked. In an embodiment, locking the telescopic tubes 502, 504, 506relative to one another also transforms the load bearing member 115 froma flexible state to a rigid state. The locking mechanism can be anymechanism suitable for locking telescopic tubes.

In an embodiment, as shown in FIG. 5B, the load bearing member 115 has acompressible body 515 that can be transformed from a flexible state to arigid state by a compressive force. In an embodiment, the conformablemember 170 is passed through the compressible body 515 and, whenexpanded, compresses the compressible body 515 to transform thecompressible body 515 from a flexible state to a rigid state. In anembodiment, the compressible body 515 may include an actuator to applyand remove a compressive force on the compressible body 515, therebytransforming the compressible body between a flexible state and a rigidstate. Examples of suitable compressive bodies include, but are notlimited to, a tubular spring or coil, a segmented or patterned tube, achain of ball bearings, a chain of cylinders, a bellow-like structure,and similar. Such compressible bodies are known and are disclosed, forexample, in U.S. Pat. No. 7,909,825.

In reference to FIG. 5C and FIG. 5D, in an embodiment, the load bearingmember 520 has a transformable body that can be transitioned from aflexible to a rigid state when the conformable member 170 engages theload bearing member 520 and provides interference in compression ortension to features of the load bearing member 520. FIG. 5C illustratesthe conformable member 170 in a deflated state positioned inside theload bearing member 520. When the conformable member 170 is moved fromthe deflated state to an inflated state, as shown in FIG. 5D, theconformable member 170 can extend radially out of the openings 540between struts 542 of the transformable load bearing member 520 totransform the load bearing member 520 from a flexible state to a rigidstate. In an embodiment, because the conformable member 170 fills in theopenings 540, the conformable member 170 prevents the translation orcompression of the load bearing member 520 back to a flexible state.

In some embodiments of a combination photodynamic implant, the loadbearing member is transformable between a flexible state and a rigidstate by radially expanding the load bearing member 115 by theconformable member 170 placed inside the load bearing member 115.Various suitable designs for the load bearing member 115 of thecombination photodynamic implant 600 are disclosed, for example, in U.S.Pat. No. 7,909,825. In an embodiment, the conformable member 170 isinserted inside the load bearing member and is expanded to transform theload bearing member 115 from a flexible state to a rigid state. In anembodiment, the design of the load bearing member 115 is such that alight-sensitive liquid can be contained inside the load bearing member115 without a conformable member 170, such that the light-sensitiveliquid can be infused directly into the load bearing member 115 toexpand the load bearing member 115.

FIG. 6A and FIG. 6B illustrate embodiments of a combination photodynamicimplant in which the load bearing member is transformable between aflexible state and a rigid state by radially expanding the load bearingmember by the conformable member 170 placed inside the load bearingmember.

As shown in FIG. 6A, in an embodiment, the load bearing member may be apatterned tube 620. The patterned tube 620 may be flexible during thedelivery of the patterned tube 620 to a bone cavity. Once the patternedtube 620 is inside the bone cavity, the conformable member 170 can beinserted into the patterned tube 620 and expanded to transform thepatterned tube 620 to a rigid state.

As shown in FIG. 6B, in an embodiment, the load bearing member is ahelical spring 630. The helical spring 630 is flexible during thedelivery of the helical spring 630 to a bone cavity. Once the helicalspring 630 is inside the bone cavity, the conformable member 170 can beinserted into the helical spring 630 and expanded to transform thepatterned tube 620 to a rigid state.

In an embodiment, as shown in FIG. 6A, in addition to the conformablemember 170 inside the load bearing member, one or more distinctconformable members 170 can be placed over the load bearing member orpatterned tube 620 placed inside the load bearing member 620 to stiffenthe load bearing member 620.

In an embodiment, as shown in FIG. 6B, the conformable member 170 islonger than the load bearing member 640 such that the conformable member170 extends outside the load bearing member 640 and achieves a conformalfit with the bone cavity into which the photodynamic implant 600 isimplanted to lock the load bearing member 640 in place inside the bonecavity. In embodiment, as shown in FIG. 6B, the conformable member 170can also be configured to extend radially out of the openings 640 in thebody of the load bearing member 640 to contact the wall of the bonecavity in which the implant 600 is implanted. In an embodiment, the loadbearing member can also be made of a tubular spring or coil, a chain ofball bearings, a chain of cylinders, a bellow-like structure, andsimilar.

In an embodiment, the load bearing member of the combinationphotodynamic implant 600 can have a diameter similar to the innerdiameter of the bone cavity into which the implant 600 is implanted suchthat the load bearing member undergoes no, or only a minimal amount of,radial expansion by the conformable member.

In reference to FIG. 6C and FIG. 6D, in an embodiment, to facilitateless invasive delivery of the combination photodynamic implant 600 to abone cavity, the load bearing member 620 can be provided with a diametersmaller than the inner diameter of the bone cavity. In an embodiment,when the conformable member 170 expands inside the load bearing member115, the load bearing member 115 is also expanded radially toapproximate the inner diameter of the bone cavity. In an embodiment, asshown in FIG. 6C and FIG. 6D, expanding the load bearing member 115 cancause the load bearing member to contract in the longitudinal direction,thereby stiffening the load bearing member 115 and locking the loadbearing 115 in place within the cavity. In an embodiment, the loadbearing member 115 has a design such that there is no foreshortening inthe longitudinal direction when the load bearing member 115 is expanded.

FIG. 7A illustrates an embodiment of a combination photodynamic implant700 in which a load bearing member 620 is at least partially enclosed bya conformable member 170. FIG. 7B is a cross-sectional side view of thecombination photodynamic implant 700 of FIG. 7A.

In an embodiment, the load bearing member is transformable between aflexible state and a rigid state. The load bearing member may have anydesign as described in regard to combination photodynamic implants 500and 600. Upon delivering the combination photodynamic implant 700 to abone cavity, the conformable member 170 can be expanded, therebyexpanding and stiffening the load bearing member 620 and, at the sametime, locking the load bearing member 620 in place within the bonecavity. In an embodiment, the load bearing member may be rigid, such asdescribed above in reference to combination photodynamic implant 400.Curing a light-sensitive liquid inside the conformable member canfurther stiffen the load bearing member and assist the load bearingmember in stabilizing the bone.

FIG. 8A and FIG. 8B illustrate an embodiment of a combinationphotodynamic implant 800 in which one or more conformable members 170may act as cams to stabilize the load bearing member 115 in a bonecavity 802 of a bone 804 into which the load bearing member 115 isimplanted. FIG. 8A shows a combination photodynamic implant 800 havingone or more conformable members 170 acting as cams to stabilize the loadbearing member 115. FIG. 8B shows such combination photodynamic implant800 in a bone cavity 802 of a bone 804. In an embodiment, the one ormore conformable members are placed about a load bearing member 115between the load bearing member 115 and the walls of the bone cavity802. In an embodiment, the one or more conformable members 170 can bepermanently attached to the load bearing member 115. In an embodiment,the one or more conformable members 170 are detachably attached to theload bearing member 115.

In an embodiment, use of multiple conformable members 170 facilitatesboth tightening to slightly increase radial tension of conformablemember 170 structures on cortical wall, as well as reversibility todecrease tension to simplify the removal of the combination photodynamicimplant 800. In an embodiment, the one or more conformable members 170may be filled with a non-curable fluid, that is a fluid that will remainflowable (i.e. non-cured) inside the one or more conformable members170, such as air or water or buffer solution, to ensure the ease ofremoval of the one or more conformable members 170.

In an embodiment, the conformable members 170 that at least partiallyenclose or encircle the load bearing member, as shown in FIG. 8B,stabilize the load bearing member, and through contact with thecancellous or cortical wall of the bone, fixate and stabilize thefractured bone. In an embodiment, this method of stabilization may notrequire the use of cross-locking screws used in load bearingintramedullary rods to facilitate longitudinal and rotational stabilityto allow the bone to heal. The placement of cross-locking screws intointramedullary rods is often time consuming, require the use oftargeting jigs and/or fluoroscopy to ensure that the cross-locking screwenters into pre-defined holes in metallic implants in particular. In anembodiment, by not requiring the use of cross-locking screws, thecombination implant illustrated in FIG. 8B can securely stabilize afractured or weakened bone, while simultaneously eliminating or limitingthe time and tissue dissection necessary to place cross-locking screwsat exact locations in particular in metallic intramedullary nails.

Referring to FIG. 8C, FIG. 8D, and FIG. 8E, in an embodiment, thecombination photodynamic implant 800 includes an internal cam structure810. The one or more conformable members 170 are acted upon by the camstructure 810 to enable user-adjustable tension or compression toincrease pressure between the load bearing member 115 containing the camstructure 810, the one or more conformable members 170 and/or thecortical bone to stabilize the load bearing member 115 in the bonecavity 802 of the bone 804. In an embodiment, use of multipleconformable members 170 facilitates both tightening via the action ofthe cam structure 810 contained in or a part of the load bearing member115 to slightly increase radial tension of the multiple conformablemembers 170 on cortical wall, as well as reversibility to decreasetension to simplify the removal of the combination photodynamic implant800. Once the conformable members 170 are expanded with the expansionfluid, and, in the instance when the expansion fluid comprises thecurable liquid, the curable liquid is hardened, rotating the internalcam structure 810 into a locking position, as shown in FIG. 8C, pushesthe conformable members into the wall of the bone cavity 802, therebyincreasing radial pressure on the cortical wall, securely locking thecombination photodynamic implant 800 inside the bone cavity 802.Rotating the internal cam structure 810 into a release position, asshown in FIG. 8D, releases the pressure on the conformable member 170,thereby enabling the repositioning or removal of the conformable members170 and, consequently, the repositioning or removal of the load bearingmember 115, as shown in FIG. 8E.

FIG. 8F shows another embodiment of the cam structure shown in FIG. 8C,FIG. 8D, and FIG. 8E where the conformable members 170 are moved in andaway from the bone 804. In an embodiment, a process known asdynamization is used to spur healing of bones, including, but notlimited to, the femur and tibia. With traditional intramedullary nailsthat are locked to the bone via cross-locking screws, if the bone doesnot begin healing quickly, the surgeon may remove one to many screws,thereby loosening the implant. Fully rigid fixation almost eliminatesmicro-motion at the fracture, and when this is not present the normalstress on the bone is gone which can slow or interrupt the healingprocess which responds positively to small motions and stress. In anembodiment, the process of dynamization can be used to loosen an implantso that the two ends of the bone move towards each other, creatingcompression across the fracture line, which also can help stimulate thehealing response particularly in the femur and tibia. In an embodiment,the cam structure shown in FIG. 8F could also be used as a dynamizationstep where the implant is slightly loosened within the bone, allowingeither the force of standing (or just putting pressure on the legwithout full standing weight) to provide compression across the fractureline, or enough loosening such that low stress and micromotion isimparted to stimulate the bone healing response.

In another embodiment, as shown in FIG. 8G, at least one or more bonefixation devices 820 including, but not limited to, cross lockingscrews, can be placed across the cortical bone 804 anywhere into thecured conformable member 170 to provide addition longitudinal orrotational stability. Simple targeting may represent a significant timeand fluoroscopy dose savings as exact match to pre-existing holes willnot be required. In an embodiment, the surgeon can place the bonefixation device 820 such as a cross locking screw anywhere along thelength of the conformable member(s) 170, thereby securing the wholecombination implant 800 and bone construct to facilitate healing orreinforcement of weakened bone.

FIG. 8H shows an embodiment of a bone implant 800 where the load bearingmember 115 is adjacent to at least one conformable member 170. In anembodiment, a load bearing member 114 is entrained by the conformablemember(s) 170 that are adjacent to the load bearing member 115longitudinally. In addition to having the conformable member 170positioned radially outward from the load bearing member 115, as shownin FIG. 8C, for example, and partially enclosing the load bearing member115 rotationally, in an embodiment, a conformable member 170 is placedat each end of the load bearing member 115 along the longitudinal axisof the load bearing member 115 holding the load bearing member 115 inplace and thereby limiting the axial movement of the load bearing member115.

FIG. 9A and FIG. 9B illustrate an embodiment of a combinationphotodynamic implant 900 of the present disclosure in which the loadbearing member 115 is modular. In an embodiment, the load bearing membercan be made up of multiple segments 902, 904 attachable to one anotherin an end to end fashion. Each segment has a first end 902 a, 904 a anda second end 902 b, 904 b, wherein the second end 902 b of a firstsegment 902 can be attached to the first end 904 a of a second segment904 adjacent to the first segment 902. In an embodiment, the second end902 b of the first segment 902 can be in the form of a male fitting andthe first end 904 a of the second segment 904 can be in the form of afemale coupling such that the first segment 902 and the second segment904 can be joined together, as shown in FIG. 9B. Any other suitablemeans for connection of the first and second segments 902, 904 can alsobe employed. In operation, the first segment 902 and the second segment904 can be delivered to a bone cavity separately and assembled insidethe bone cavity. In an embodiment, to help ensure that the first segment902 and the second segment 904 are aligned, the load bearing member canbe assembled over an obturator. Once the modular load bearing member 115is assembled inside the bone cavity, the conformable member 170 can beinserted into the assembled load bearing member 115 and expanded toincrease the strength and rigidity of the load bearing member 115. In anembodiment, the conformable member 170 can expand outside of the loadbearing member 115, as shown in FIG. 9B. In this manner, the conformablemember 170 can bias the segments of the load bearing member 115 towardone another, thereby ensuring that the load bearing member 115 does notcome apart. Moreover, in this manner, the conformable member may be usedto add rotational and longitudinal stability to the load bearing member115. In an embodiment, the inner void of the modular load bearing membermay sealed so that a light-sensitive liquid can be infused into theinner void of the modular load bearing member 115 without a balloon.

FIGS. 10A-10F illustrate an embodiment of method steps for implanting anexpandable portion of an intramedullary implant of the presentdisclosure within the intramedullary space of a weakened or fracturedbone. A minimally invasive incision (not shown) is made through the skinof the patient's body to expose a fractured bone 1002. The incision maybe made at the proximal end or the distal end of the fractured bone 1002to expose the bone surface. Once the bone 1002 is exposed, it may benecessary to retract some muscles and tissues that may be in view of thebone 1002. As shown in FIG. 10A, an access hole 1010 is formed in thebone by drilling or any other suitable methods. The access hole 1010 mayhave any suitable diameter. In an embodiment, the access hole 1010 has adiameter of about 3 mm to about 10 mm. In an embodiment, the access hole1010 has a diameter of about 3 mm.

The access hole 1010 extends through a hard compact outer layer 1020 ofthe bone into the relatively porous inner or cancellous tissue 1025. Forbones with marrow, the medullary material should be cleared from themedullary cavity prior to insertion of the inventive device. Marrow isfound mainly in the flat bones such as hip bone, breast bone, skull,ribs, vertebrae and shoulder blades, and in the cancellous material atthe proximal ends of the long bones like the femur and humerus. Once themedullary cavity is reached, the medullary material including air,blood, fluids, fat, marrow, tissue and bone debris should be removed toform a void. The void is defined as a hollowed out space, wherein afirst position defines the most distal edge of the void with relation tothe penetration point on the bone, and a second position defines themost proximal edge of the void with relation to the penetration site onthe bone. The bone may be hollowed out sufficiently to have themedullary material of the medullary cavity up to the cortical boneremoved. Any suitable method for removing the medullary material may beused. Suitable methods include, but are not limited to, those describedin U.S. Pat. No. 4,294,251 entitled “Method of Suction Lavage,” U.S.Pat. No. 5,554,111 entitled “Bone Cleaning and Drying system,” U.S. Pat.No. 5,707,374 entitled “Apparatus for Preparing the Medullary Cavity,”U.S. Pat. No. 6,478,751 entitled “Bone Marrow Aspiration Needle,” andU.S. Pat. No. 6,358,252 entitled “Apparatus for Extracting Bone Marrow.”

As shown in FIG. 10B, a guidewire 1028 may be introduced into a bonecavity 1003 the bone 1002 via the access hole 1010 and placed betweenbone fragments 1004 and 1006 of the bone 1002 to cross the location of afracture 1005. The guidewire 1028 may be delivered into the bone cavity1003 and positioned across the location of the break 1005 so that theguidewire 1028 spans multiple sections of bone fragments.

Next, as shown in FIG. 10B and FIG. 10C, a combination photodynamicimplant of the present disclosure can be delivered over the guidewire1028 into the bone cavity 1003. The combination photodynamic implant isplaced to cross the fracture 1005 and spans the bone fragments 1004 and1006 of the bone 1002. In an embodiment, the load bearing member 115 isdelivered to the bone cavity 1003 first and then the conformable member170 is delivered to the bone cavity and is associated with the loadbearing member 115. It should be noted that although as illustrated thedelivery of the load bearing member 115 precedes the delivery of theconformable member 170, the sequence of delivery will depend on thedesign of the combination photodynamic implant utilized in theprocedure, design of the combination photodynamic implant, user'spreference or combination thereof.

Once the conformable member 170 and the load bearing member 115 are inthe desired position, the guidewire 1028 may be removed. The location ofthe conformable member 170 and the load bearing member 115 is determinedusing at least one radiopaque marker 1030 which may be detectable fromthe outside or the inside of the bone 1002. Next, the conformable member170 is expanded by adding the expansion fluid to the conformable member170 through the inner void of the delivery catheter 150, as shown inFIG. 10D. As the conformable member 170 expands, the conformable member170 stiffens the load bearing member 115, lock the load bearing member115 in place, or both, depending on the design of the combinationphotodynamic implant utilized in the procedure.

In the embodiment where a light-sensitive liquid is used to expand theconformable member 170, a delivery system which contains alight-sensitive liquid is attached to the port of the delivery catheter150 in communication with the inner void of the delivery catheter 150.The light-sensitive liquid is then infused through the inner void in thedelivery catheter 150 into the conformable member 170. This addition ofthe light-sensitive liquid within the conformable member 170 causes theconformable member 170 to expand, as shown in FIG. 10D. FIG. 2, FIG. 3Aand FIG. 3B also show an example of a system for expanding theconformable member 170 with a light-sensitive liquid 165. Onceorientation of the bone fragments 1004 and 1006 as well as the positionof the load bearing member 115 and conformable member 170 are confirmedto be in a desired position, the light-sensitive liquid may be hardenedwithin the conformable member 170, as shown in FIG. 10E, such as byillumination with a visible emitting light source. In an embodiment,during the curing step, a syringe housing a cooling media may beattached to the proximal end of the insertion catheter and continuouslydelivered to the conformable member 170. The cooling media can becollected by connecting tubing to the distal end of the inner lumen andcollecting the cooling media via the second distal access hole. Afterthe light-sensitive liquid has been hardened, the light source may beremoved from the device. Alternatively, the light source may remain inthe conformable member 170 to provide increased rigidity.

Referring to FIG. 10F, the expanded conformable member 170 may bereleased from the delivery catheter 150 by any suitable method, therebyforming a combination photodynamic implant 1030. In an embodiment, theexpanded conformable member 170 achieves a conformal fit with the bonecavity 1025 to provide longitudinal and rotational stability to thecombination photodynamic implant 1030. Additionally or alternatively,one or more fasteners 102 may be inserted through the bone into thephotodynamic implant 1030 to further stabilize the photodynamic implantwithin the bone cavity 1025 of the fractured bone 1002. In anembodiment, an external bone plate 1130 may be attached to thecombination photodynamic implant 1030, as shown in FIG. 10F.

In one aspect, a combination photodynamic device includes at least oneload bearing member designed to reside in a cavity of a fractured orweakened bone, and at least one conformable member connected to the atleast one load bearing member. The at least one load bearing member actsas an internal bone fixation and stabilization device. The at least oneconformable member is configured to be expandable from a deflated stateto an inflated state to anchor the at least one load bearing memberinside the cavity.

In an embodiment, a combination photodynamic device of the presentdisclosure includes a load bearing member and one or more conformablemembers associated with the load bearing member, the conformable memberexpandable from a deflated state to an inflated state with an expansionfluid. The load bearing member is designed to reside inside of a cavitywithin a bone and act as internal bone fixation and stabilizationdevice, while the conformable member is designed to anchor the loadbearing member inside the intramedullary cavity to provide longitudinaland rotational stability to the load bearing member. In an embodiment,expanding the conformable member from a deflated state to an expandedstate locks the load bearing member in place within a bone cavity intowhich its implanted as well as transforms the load bearing member from aflexible state to a rigid state.

In one aspect, a method for bone repair and stabilization includes:inserting a load bearing member into a cavity of a fractured or weakenedbone; inserting one or more conformable members into the cavity;engaging the one or more conformable members with the load bearingmember; and expanding the conformable member with an expansion fluid,thereby anchoring the load bearing member inside the cavity andproviding longitudinal and rotational stability to the load bearingmember during the healing process.

In an embodiment, a method for bone repair and stabilization thatincludes inserting a load bearing member into a cavity of a fractured orweakened bone, inserting one or more conformable members into thecavity, associating the one or more conformable members with the loadbearing member, and expanding the conformable member with an expansionfluid, thereby anchoring the load bearing member inside theintramedullary cavity, providing longitudinal and rotational stabilityto the load bearing member during the healing process, transforming theload bearing member from a flexible state to a rigid state, contributingto fixating and stabilizing a fractured or a weakened bone, providinglongitudinal and rotational stability to a fractured or a weakened boneduring the healing process or combinations thereof.

In one aspect, a combination photodynamic device kit includes: at leastone expansion fluid; a delivery catheter having an elongated shaft witha proximal end, a distal end, and a longitudinal axis therebetween; aconformable member releasably engaged to the distal end of the deliverycatheter and wherein the delivery catheter has an inner void for passingthe at least one expansion fluid into the conformable member; and a loadbearing member, wherein the load bearing member can be engaged with theconformable member.

In an embodiment, there is provided a combination photodynamic devicekit that includes a unit dose of at least one expansion fluid, adelivery catheter having an elongated shaft with a proximal end, adistal end, and a longitudinal axis therebetween, wherein a conformablemember is releasably engaged to the distal end of the delivery catheterand wherein the delivery catheter has an inner void for passing the atleast one expansion fluid into the conformable member, and a loadbearing member, wherein the load bearing member can be associated withthe conformable member. In an embodiment, the kit includes a pluralityof conformable members of different sizes or shapes. In an embodiment,the kit includes a light source.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that several of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or application. Various presently unforeseen orunanticipated alternatives, modifications, variations, or improvementstherein may be subsequently made by those skilled in the art.

1. A combination photodynamic device comprising: at least one loadbearing member designed to reside in a cavity of a fractured or weakenedbone, the at least one load bearing member acting as an internal bonefixation and stabilization device; at least one conformable memberconnected to the at least one load bearing member, the at least oneconformable member configured to be expandable from a deflated state toan inflated state to anchor the at least one load bearing member insidethe cavity.
 2. The device of claim 1, wherein the at least oneconformable member is expandable from a deflated state to an inflatedstate using an expansion fluid.
 3. The device of claim 1, wherein the atleast one conformable member is a balloon.
 4. The device of claim 1,wherein the at least one conformable member is designed to transform theat least one load bearing member from a flexible state for delivery toor removal from the cavity of the bone to a rigid state for implantationwithin the cavity of the bone.
 5. The device of claim 1, wherein the atleast one conformable member is detachably or removably attached to theat least one load bearing member.
 6. The device of claim 1, wherein theat least one load bearing member has a threaded end so that the at leastone load bearing member can be screwed into the bone.
 7. The device ofclaim 1, wherein the at least one load bearing member is an elongatedrod or an intramedullary nail.
 8. The device of claim 1, wherein the atleast one load bearing member is made of a flexible material.
 9. Thedevice of claim 1, wherein the at least one load bearing member includesa plurality of nested tubes telescopically slidable relative to oneanother.
 10. The device of claim 1, wherein the at least one loadbearing member has a compressible body that can be transformed from aflexible state to a rigid state by a compressive force.
 11. The deviceof claim 1, wherein the at least one load bearing member istransformable between a flexible state and a rigid state by radiallyexpanding the at least one load bearing member using the conformablemember placed inside the load bearing member.
 12. The device of claim 1,wherein the at least one load bearing member is as at least partiallyenclosed by the at least one conformable member.
 13. The device of claim1, wherein the at least one load bearing member is adjacent to the atleast one conformable member.
 14. The device of claim 1, wherein the atleast one load bearing member is a flexible patterned tube or a flexiblehelical spring, and the at least one conformable member is configured tobe inserted in the at least one load bearing member and expanded totransform the at least one load bearing member to a rigid state.
 15. Thedevice of claim 1, further comprising one or more holes in the at leastone load bearing member and/or at least one conformable member forreceiving one or more fasteners to secure the device to the bone. 16.The device of claim 1, further comprising a cam structure attached tothe at least one load bearing member and configured to act upon the atleast one conformable member to increase pressure between the at leastone load bearing member containing the cam structure, the at least oneconformable member, and/or the weakened or fractured bone to stabilizethe load bearing member in the cavity of the bone.
 17. The device ofclaim 1, wherein the at least one load bearing member includes one ormore segments.
 18. A combination photodynamic device kit comprising: atleast one expansion fluid; a delivery catheter having an elongated shaftwith a proximal end, a distal end, and a longitudinal axis therebetween;a conformable member releasably engaged to the distal end of thedelivery catheter and wherein the delivery catheter has an inner voidfor passing the at least one expansion fluid into the conformablemember; and a load bearing member, wherein the load bearing member canbe engaged with the conformable member.
 19. The kit of claim 18, furthercomprising a plurality of conformable members of different sizes orshapes.
 20. A method for bone repair and stabilization comprising:inserting a load bearing member into a cavity of a fractured or weakenedbone; inserting one or more conformable members into the cavity;engaging the one or more conformable members with the load bearingmember; and expanding the conformable member with an expansion fluid,thereby anchoring the load bearing member inside the cavity andproviding longitudinal and rotational stability to the load bearingmember during the healing process.
 21. The method of claim 20, whereinthe load bearing member is flexible when inserted into the cavity, andbecomes rigid upon expanding the conformable member with an expansionfluid.